NCT00228150已完成2 期
A Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 564
- 试验地点
- 13
- 主要终点
- Time to disability warranting introduction of Ldopaor a dopamine agonist.
研究概览
简要总结
The primary objective is to assess the effect of SR57667B at the dose of 4 mg/d on the progression of Parkinson symptoms in patients with early PD. The primary outcome will be the time to progression of disability warranting initiation of L-dopa or a dopamine agonist. Secondary outcomes will comprise assessments of symptoms, activities of daily living and global clinical status.
详细描述
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients.
- •Age >=35 years at screening.·
- •Diagnosis of Parkinson's syndrome, on at least two of the three key Parkinson's symptoms, i.e. resting tremor, bradykinesia and rigidity.
- •Duration of the disease of less than 3 years since diagnosis·
- •Modified Hoehn and Yahr stage <= 2.
- •Untreated patients.
- •Generally healthy and ambulatory.
- •Patient has given his informed written consent and is capable of following study procedures.
排除标准
- •Any indication of forms of parkinsonism other than PD.
- •Severe resting tremor.
- •Presence of either dyskinesia, fluctuations, or loss of postural reflexes·
- •Treatment with L-Dopa, dopamine agonist, amantadine, anticholinergics, catechol-o-methyltransferase (COMT ) inhibitors, selegiline, dopamine receptor antagonists, catecholamine depleters, indirect dopamine agonists or alphamethyldopa.
- •Electroconvulsive therapy (ECT).
- •Use of CYP3A4 strong, and moderate inducers or inhibitors.
- •Participation in another clinical trial with an investigational drug within two months prior to randomization.
- •Dementia, uncontrolled depression, psychotic disorder.
- •History of substance-related disorders including alcohol or other substance use disorders.
- •Females of child bearing potential.
- •Evidence (detected by history, physical examination and/or laboratory/ECG tests) of any clinically significant or unstable medical disorder that could interfere with the patient's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug.
- •Alterations of laboratory tests or ECG findings of potential clinical significance.
结局指标
主要结局
Time to disability warranting introduction of Ldopaor a dopamine agonist.
次要结局
- Unified Parkinson's Disease Rating Scale (UPDRS)
研究者
研究点 (13)
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